Virus production for clinical gene therapy

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

10 Citations (Scopus)


Gene therapy is becoming increasingly relevant for the treatment of prominent human diseases. Viral vectors are currently used in more than 50% of the gene therapy clinical trials, most of them aimed at cancer diseases. Clearly, the increasing needs of high-quality viral preparations required the elimination of process bottlenecks, streamlining the development of the viral into a real-world clinical tool . Virus production for clinical gene therapy can be a limiting step because many virus generation protocols rely on labor-intensive, bench-scale methods; robust, cost-effective strategies for the delivery of clinical-grade viruses are thus essential for the future of gene therapy. A comprehensive picture of key aspects on the integration of upstream and downstream processing is addressed in this chapter, by describing the case study of recombinant budded baculoviruses for gene therapy; scalable methods are described in detail as well as mandatory characterization techniques for a proper and complete quality assessment of the viral vectors.

Original languageEnglish
Title of host publicationGene Therapy of Cancer
Subtitle of host publicationMethods and Protocols
EditorsWolfgang Walther, Ulrike Stein
Place of PublicationNew York
PublisherHumana Press
Number of pages24
ISBN (Print)978-1-934115-85-5, 978-1-59745-561-9
Publication statusPublished - 2009

Publication series

NameMethods in Molecular Biology
PublisherHumana Press
ISSN (Print)1064-3745


  • Analytical tools
  • characterization
  • recombinant baculoviruses
  • upstream and downstream processing
  • viral vectors


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